Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Chemotherapy for Leukemia
NCT ID: NCT01297543
Last Updated: 2016-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
45 participants
INTERVENTIONAL
2011-03-31
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Consolidation Group A
Low dose CLT-008 (human myeloid progenitor cells)
human myeloid progenitor cells
Single intravenous injection/infusion
G-CSF
Background therapy
Consolidation Group B
Intermediate dose CLT-008 (human myeloid progenitor cells)
human myeloid progenitor cells
Single intravenous injection/infusion
G-CSF
Background therapy
Consolidation Group C
Intermediate dose CLT-008 (human myeloid progenitor cells), no G-CSF
human myeloid progenitor cells
Single intravenous injection/infusion
Consolidation Group D
High dose CLT-008 (human myeloid progenitor cells)
human myeloid progenitor cells
Single intravenous injection/infusion
G-CSF
Background therapy
Induction Group A1 (cytarabine 7+3)
G-CSF
G-CSF
Background therapy
Induction Group A2 (cytarabine 7+3)
Intermediate dose CLT-008 (human myeloid progenitor cells)
human myeloid progenitor cells
Single intravenous injection/infusion
G-CSF
Background therapy
Induction Group A3 (cytarabine 7+3)
High dose CLT-008 (human myeloid progenitor cells)
human myeloid progenitor cells
Single intravenous injection/infusion
G-CSF
Background therapy
Induction Group B1 (cytarabine HIDAC)
G-CSF
G-CSF
Background therapy
Induction Group B2 (cytarabine HIDAC)
Intermediate dose CLT-008 (human myeloid progenitor cells)
human myeloid progenitor cells
Single intravenous injection/infusion
G-CSF
Background therapy
Induction Group B3 (cytarabine HIDAC)
High dose CLT-008 (human myeloid progenitor cells)
human myeloid progenitor cells
Single intravenous injection/infusion
G-CSF
Background therapy
Interventions
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human myeloid progenitor cells
Single intravenous injection/infusion
G-CSF
Background therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* AML, ALL or MDS
* Planned treatment with cytarabine-based chemotherapy regimen
* Adequate hepatic, renal, hematologic, cardiac and respiratory function
Exclusion Criteria
* Pregnant or nursing
18 Years
ALL
No
Sponsors
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Department of Health and Human Services
FED
Cellerant Therapeutics
INDUSTRY
Responsible Party
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Locations
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Moores UCSD Cancer Center
La Jolla, California, United States
University of California San Francisco Medical Center
San Francisco, California, United States
Stanford Hospital and Clinics
Stanford, California, United States
Loyola University Medical Center, Cardinal Bernardin Cancer Center
Maywood, Illinois, United States
Indiana Blood and Marrow Transplantation, LLC
Beech Grove, Indiana, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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Cellerant Therapeutics, Inc.
Other Identifiers
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CLT008-02
Identifier Type: -
Identifier Source: org_study_id
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